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Complementary medicines reforms

Related information

Over the past two years, the Therapeutic Goods Administration (TGA) has undertaken a series of reforms to complementary medicines to improve community confidence in the safety and quality of these medicines.

These guidelines provide information for sponsors and applicants on the type of evidence that is required to support indications for listed complementary medicines; and help sponsors understand their regulatory obligations in relation to holding evidence to support indications that are made for those medicines.

Permitted (coded) indications project

As of June 2014, the proposed legislative amendments associated with the permitted indications reform were put on hold pending broader consideration of the Government's deregulatory agenda in the context of the TGA.

In the interim, the TGA will proceed with the aspects of the reform that can be implemented within the existing regulatory framework. In particular, the updating of the indications list in the listed medicines application portal will be progressed notwithstanding any delay to legislative amendments for the broader permitted indications reform.

The TGA will continue to work with industry to ensure that an updated, comprehensive list of indications meets the needs of complementary medicine industry and improves compliance with the regulatory framework. Once finalised, the TGA will proceed to make the list available through the online listed medicines application portal.

Investigation processes for advertising breaches

A standard operating procedure for investigating advertising breaches is now being used by the TGA. The TGA is currently finalising a workflow system for complaints handling and to facilitate reporting of non-compliance with advertising requirements.